Multicenter Validation of a Predictor Model of ACHD Patients and Cardiac Surgery

Cardiac Surgery Clinical Trial

Official title:

Novel Model of Preoperative Predictors of Outcome for Adults Undergoing Congenital Cardiac Surgery: Multicenter Model Validation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04787705
• Other study ID #: 18-5588
• Status: Active, not recruiting
• Start date: March 10, 2020
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This multicentre study is to validate prediction modeling for the ACHD population undergoing cardiac surgery. The validation of this prediction model will support and generalize its use as a risk stratification tool in the ACHD population.

Description:

The prediction model resulted from a preceding study, which uniquely based on comorbidities, was developed using 783 adults (>16 years) who underwent surgery for congenital heart disease at Toronto General Hospital (TGH) during 2004-2015. It identifies five pre-operative variables, namely presence of cognitive impairment, hepatic function, >3 chest incisions, anatomy diagnosis, and Body Mass Index <20 and >28, as significant predictors of composite adverse outcomes such as in-hospital mortality, prolonged ventilation (exceeding 7 days) and acute kidney injury. This newly prediction model developed in a single-center has only been internally validated. It requires further external validation to demonstrate its utility in ACHD populations who require cardiac surgery in other cardiac institutions both nationally and internationally.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 547
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• all ACHD patients >16 years of age undergoing cardiac surgery requiring an open sternotomy or thoracotomy and cardiopulmonary bypass (CPB) or CPB standby at TGH and the collaborating institutions from April 2019.

Exclusion Criteria:

• CHD patients <16 years of age
• ACHD patients undergoing chest wall debridement and chest re-explorations for bleeding
• Non-cardiac surgery procedures and cardiology laboratory interventions

Related Conditions & MeSH terms

• Adult Congenital Heart Disease
• Cardiac Surgery
• Heart Defects, Congenital
• Heart Diseases

Locations

Country	Name	City	State
Canada	Toronto General Hospital - University Health Network	Toronto	Ontario

Sponsors (5)

Lead Sponsor	Collaborator
University Health Network, Toronto	Auckland City Hospital, Melbourne Health, Montreal Heart Institute, Providence Healthcare

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite adverse events	The composite adverse outcome is defined by in-hospital mortality, prolonged ventilation (exceeding seven days), or acute kidney injury requiring dialysis.	30 days from the day of surgery.
Secondary	One-year mortality	One-year is defined as 365 days from the day of surgery.	365 days from the day of surgery.